Post Hoc Analysis: Erenumab Reduces Migraine Functional Impact

Data showed erenumab helped improve migraine functional impact when compared with placebo.

Data gleaned from 2 phase 3 randomized trials on erenumab revealed migraineurs who took the treatment reported superior outcomes on the Migraine Functional Impact Questionnaire (MFIQ) compared with those who received placebo.

Specifically, findings published in Headache: The Journal of Head and Face Pain showed patients treated with erenumab “had greater reductions in the functional impact of migraine, providing insight into treatment benefits that extend beyond improvements in clinical status and health-related quality of life previously reported based on clinical end points and other PROs [patient-reported outcomes],” authors wrote.

Erenumab was approved in 2018 and is administered monthly via self-injection of a 70- or 140-mg dose. It works to block the calcitonin gene-related peptide (CGRP) receptor, which is believed to play a crucial role in the pathophysiology of migraine.

The MFIQ was designed to assess migraineurs’ physical function (PF), social function (SF), emotional function (EF), and usual activities (UAs) in a 7-day recall period. The MFIQ also “assesses difficulty in performing particular acts and tasks, as they attempt to ‘power through’ their activities,” researchers explained, as that is a metric that is not captured in other commonly used migraine questionnaires.

To better understand MFIQ-reported outcomes among patients receiving erenumab, investigators analyzed data from ARISE and STRIVE clinical trials. Previously reported data from these studies revealed erenumab treatment led to statistically significant decreases in number of monthly migraine days, reduction in physical impairment (PI), and improvements in health-related quality of life compared with placebo.

The current exploratory, post hoc analysis included information from 1532 participants who logged MQIF and other PRO responses in an electronic diary and a headache diary. All participants had episodic migraine and were randomized to erenumab or placebo.

Analyses revealed:

  • In ARISE, greater reductions from baseline to month 3 were observed for 70 mg versus placebo for PF (least squares mean [LSM] −3.2; 95% CI, −6.4 to −0.1; P = .046) and EF (LSM −4.0; 95% CI, −7.3 to −0.7; P = .019) domain scores
  • In STRIVE, between-group differences reflected reductions from baseline to the average of months 4–6 that favored erenumab on all 4 MFIQ domain scores
  • Reductions in impact for 70 mg compared with placebo were −4.3 (95% CI, −6.8 to −1.7; P < .001) for PF, −4.0 (95% CI, −6.3 to −1.7; P < .001) for UA, −3.7 (95% CI, −6.1 to −1.2; P = .003) for SF, and −5.3 (95% CI, −7.9 to −2.6; P < .001) for EF domain scores
  • Improvements were observed for 140 mg versus placebo with between-group differences of −5.7 (95% CI, −8.2 to −3.2; P < .001) in PF, −5.1 (95% CI, −7.5 to −2.8; P < .001) in UA, −5.0 (95% CI, −7.4 to −2.6; P < .001) in SF, and −7.2 (95% CI, −9.9 to −4.5; P < .001) in EF domain scores
  • There were greater improvements in the overall impact on UA score for 70 mg (LSM −4.3 [95% CI, −7.0 to −1.7]; P = .001) and 140 mg (LSM −5.3 [95% CI, −8.5 to −3.2]; P < .001) versus placebo

“Individuals with migraine will often try to carry on with their daily work and responsibilities despite migraine attacks, so understanding the level of difficulty experienced when performing tasks, in addition to how often migraine attacks prevent or restrict them from completing tasks, provides a more comprehensive picture of the impact of migraine on patient lives,” authors explained.

More research is needed to better understand the performance of the MFIQ outside of clinical trials. Due to differences in study length, researchers caution changes MFIQ scores may be more robust in the longer STRIVE trial, marking a limitation to the current analysis.

“Improvements in functional impact may develop more slowly, especially for SF, and thus may not have fully emerged after 3 months of treatment in the ARISE trial,” they added. Findings were also limited as only patients with episodic migraine were included in the 2 trials.

“Measuring the functional impacts of migraine is critical for assessing disease severity and guiding treatment decisions, as an increased understanding of migraine-related disability can better inform effective treatment decisions,” researchers concluded.

Reference

Kawata AK, Ladd MK, Lipton RB, et al. Reducing the physical, social, and emotional impact of episodic migraine: results from erenumab STRIVE and ARISE phase III randomized trials. Headache. Published online February 8, 2022. doi:10.1111/head.14258